The company utilizes third-party suppliers for the manufacturing and assembly of certain components of the Senza SCS system, including some single- or sole-source suppliers. While alternate sources have been qualified for key components, the company primarily relies on single sources to reduce costs. Alternate suppliers are maintained to mitigate supply chain risks in case relationships with single- or sole-source suppliers end. Manufacturing operations adhere to FDA regulations and international certifications such as EU MDR and ISO13485:2016. Pro-Tech Design and Manufacturing, Inc. serves as a single-source supplier responsible for inspection, labeling, packaging, and sterilization of the Senza SCS system under a supply agreement initially established in July 2014 and amended in June 2020 to include automatic annual renewals. Stellar Technologies, Inc. supplies percutaneous leads, lead extenders, and surgical leads under a manufacturing agreement that began on July 1, 2009, with automatic renewal following the initial term's expiration in 2014 and an amendment dated July 1, 2014.
Nevro's Comment on Supply Chain
The company utilizes third-party suppliers for the manufacturing and assembly of certain components of the Senza SCS system, including some single- or sole-source suppliers. While alternate sources have been qualified for key components, the company primarily relies on single sources to reduce costs. Alternate suppliers are maintained to mitigate supply chain risks in case relationships with single- or sole-source suppliers end. Manufacturing operations adhere to FDA regulations and international certifications such as EU MDR and ISO13485:2016. Pro-Tech Design and Manufacturing, Inc. serves as a single-source supplier responsible for inspection, labeling, packaging, and sterilization of the Senza SCS system under a supply agreement initially established in July 2014 and amended in June 2020 to include automatic annual renewals. Stellar Technologies, Inc. supplies percutaneous leads, lead extenders, and surgical leads under a manufacturing agreement that began on July 1, 2009, with automatic renewal following the initial term's expiration in 2014 and an amendment dated July 1, 2014.
Sources:
Nevro Corp 's official press releases and regulatory filings; CSIMarket.com's supply-chain research; and the financial filings and press releases of other companies cited in this report.
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